Cognitive Function in Elderly Marathon Runners (APSOEM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Robert Winker, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01045031
First received: January 7, 2010
Last updated: May 31, 2016
Last verified: May 2016
  Purpose

There is substantial research on the effects of physical exercise on cognitive functions. However, less attention has been paid on the requirements of training intensity and length to enhance cognitive abilities in the elderly. To the investigators knowledge no studies have evaluated the effects of extensive endurance exercise training on cognitive functions by studying elderly marathon runners and bicyclists. On the basis of the scientific literature published so far it is not known whether the beneficial impact of endurance exercise training depends on the intensity of training.

The investigators therefore designed a cohort study with adequate power in order to evaluate the effects of intensive endurance exercise training on cognition. This trial, an Austrian prospective cohort study in cognitive function of elderly marathon-runners (APSOEM) is being conducted and will compare neuropsychological performance outcomes of elderly marathon runners or bicyclists with controls matched concerning age, education years, occupation, and verbal intelligence.


Condition
Cognitive Decline

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Austrian Prospective Cohort Study in Cognitive Function of Elderly Marathon-runners

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Hypothesis will be tested at the second follow-up examinations.

  • Brain-derived Neurotrophic Factor (BDNF) [ Time Frame: Baseline and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self Rating by Questionnaires [ Time Frame: Baseline and 5 years ] [ Designated as safety issue: No ]
    The following self rating scales were used: WHO-5 Quality of Life Assessment (Braeher, E., Muehlan, H., Albani, C., & Schmidt, S. (2007). Testing and standardization of the German version of the EUROHIS-QOL and WHO-5 quality-of life-indices. Diagnostica, 53(2), 83-96.). Range: 0 - 25, higher scores indicate better quality of life.

  • Insulin-like Growth Factor (IGF-1) [ Time Frame: Baseline and 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Apolipoprotein E4 genotype, Insulin-like growth factor-1, Brain-derived neurotrophic factor, rs6265-Genotype

Enrollment: 114
Study Start Date: December 2008
Estimated Study Completion Date: December 2018
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper ("Krone") and one in an Austrian bicyclist journal ("Bicyclist Sports"). The controls were matched according to age, sex and years of education
marathon athletes
Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Marathon runners, bicyclists and controls from the greater Vienna area
Criteria

Inclusion Criteria:

  • Current Marathon runners or marathon bicyclists and controls from the greater Vienna area

Exclusion Criteria:

  • Current of past neurotoxic exposure
  • Not German as native language
  • Diseases, that might affect central nervous system (stroke, meningitis, meningeoma, hydrocephalus,..)
  • Manifest cardiovascular disease
  • Alcoholism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Winker, Ass. Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01045031     History of Changes
Other Study ID Numbers: Grant Project number 12979 
Study First Received: January 7, 2010
Results First Received: March 15, 2016
Last Updated: May 31, 2016
Health Authority: Austria: Ethikkommission
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medical University of Vienna:
cognitive function, aging, brain-derived neurotrophic factor

ClinicalTrials.gov processed this record on August 25, 2016